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Pink Sheet - “Lame Duck” Congress Has High Stakes For Pharma Companies

Executive Summary

Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph reform could have ripple effects on the plans to modernize the US


An eleventh hour stand-off in the US Senate between two GOP members is threatening to derail the enactment of two bills important to segments of the pharmaceutical industry – and the fallout could include disruption in the roll out of the new structure for FDA’s Office of New Drugs.


Pink Sheet - Project Renewal: US FDA's Plan To Update Generic Cancer Drug Labels Depends On NDA Holders

Executive Summary

Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation of reference product holders who would actually have to submit the supplement.


The US FDA is embarking on a mission to update labeling of generic chemotherapy drugs, but the initiative's success may depend upon the cooperation of reference product sponsors.


Pink Sheet - LPAD Approval Pathway Is Not Saving Antimicrobial Development

Executive Summary

US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations.

Bundle of money and pack of medication tablets or drug pills, close-up. Expensive health care concept, selective focus

Pink Sheet - Off The Clock? The New Timelines Of “Real-Time Review”

Executive Summary

When is a two-week review not a two-week review? When it is part of the US FDA’s Oncology Center of Excellence “real-time review” pilot program. The “left shifted” review pilot is off to a good start, but it may be time to rethink the concept of FDA review clocks.

Pink Sheet - CDER Recruitment Wins Begin Outnumbering Losses

Executive Summary

US FDA's drug center has been hiring more employees than it has lost over the last few months and hopes the Office of New Drugs reorganization will help retention.


The US FDA's new hiring programs are beginning to pay dividends, as incoming employees are outnumbering departures within the Center for Drug Evaluation and Research.


Pink Sheet - US FDA’s Assessment Aid May Spell The End Of Dueling Advisory Committee Briefing Packages

Executive Summary

Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of oncology applications, template could become the basis for a consolidated advisory committee briefing document.


Pink Sheet - Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When

Executive Summary

Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.


Pink Sheet - Keeping Up With “The Energizer Bunny”: US FDA Commissioner Gottlieb As A Boss

Executive Summary

Three center directors agree that Gottlieb’s facility for public communications is a boon for FDA – and that the commissioner is appropriately hands-off when it comes to day-to-day decisions on scientific or policy issues.


US FDA Commissioner Scott Gottlieb has been getting generally high marks from the agency’s external stakeholders, and it seems he is just as popular with some of the key managers who report to him.


Pink Sheet - Unlicensed Stem Cell Clinics Are 'Surrogate' For Right To Try, US FDA's Marks Says

Executive Summary

CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.


Asked about the US's Right to Try law, Center for Biologics Evaluation and Research Director Peter Marks said he needed to "carefully side-step" the issue, but he was willing to discuss what he called a surrogate marker for the new framework.



FDA plans to release guidance soon that will make it easier to get a cancer companion diagnostic approved for use with an entire class of drugs, FDA Commissioner Scott Gottlieb told BioCentury.


Class-wide labeling would give physicians more flexibility to prescribe drugs and reduce the likelihood of patients having to undergo multiple biopsies to determine whether specific drugs could be of benefit, Gottlieb said.